Pharmicell: "Stem Cell Therapy Reduces 5-Year Mortality Risk by 86% in Patients with Alcoholic Liver Cirrhosis"

Pharmicell, a leading stem cell company in Korea, announced on September 11 that a new study has found that treatment using bone marrow-derived mesenchymal stem cells (BM-MSC) significantly improves long-term survival rates for patients with alcoholic liver cirrhosis.

The research team led by Professor Kim Moonyoung at Yonsei University Wonju College of Medicine analyzed clinical trial data using stem cells supplied by Pharmicell, combined with sample cohort data from the National Health Insurance Service-National Sample Cohort (NHIS-NSC). The study confirmed that the risk of death for patients with alcoholic liver cirrhosis who received stem cell treatment was reduced by up to 86% after five years compared to the control group.

The study, titled "Autologous Bone Marrow-Derived Mesenchymal Stem Cell Transplantation in Patients with Decompensated Liver Cirrhosis: Real-World Clinical Evidence from a Population-Based Cohort," was recently published in the international journal for gastroenterology, Gut and Liver.

To compare survival rates between the stem cell treatment group and the non-treatment group, the research team used exposure density sampling (EDS) for dynamic matching. This is a highly reliable epidemiological approach that reduces immortal time bias. The analysis showed that in the Kaplan-Meier survival curves, the mortality rates at three and five years after treatment were significantly lower in the stem cell group than in the control group. The five-year cumulative mortality rate was 11.3% in the stem cell group, compared to 42.1% in the control group.

The research team used two statistical models to increase the accuracy of the analysis. Even in the basic model, which considered only age and gender, the five-year mortality risk for the stem cell group decreased by 82% compared to the control group. In the advanced analysis model, which also considered liver function-related biochemical indicators (ALT, AST, GGT), the risk of death decreased by up to 86%. This indicates that stem cell treatment can significantly improve long-term survival for patients with alcoholic liver cirrhosis.

A Pharmicell representative stated, "This research provides scientific evidence that Pharmicell's stem cell therapy can improve long-term survival rates for patients with liver cirrhosis," adding, "Currently, Pharmicell is conducting a Phase 3 clinical trial of Cellgram-LC for patients with alcoholic liver cirrhosis, the same condition."

The representative continued, "Based on these research results, we are confident in the success of the Phase 3 clinical trial," and emphasized, "Pharmicell will devote all of its resources to ensure the commercialization of stem cell therapy for patients with alcoholic liver cirrhosis."

Liver cirrhosis is a condition involving permanent damage to liver tissue and is a leading cause of end-stage liver disease. In particular, alcoholic liver cirrhosis accounts for up to 40% of liver transplant cases in the United States. The one-year mortality rate for patients with decompensated alcoholic liver cirrhosis can reach as high as 50%. Although liver transplantation is the most effective treatment, many patients miss the opportunity for treatment due to donor shortages and requirements for alcohol abstinence. Pharmicell's stem cell therapy could serve as an effective bridging therapy for patients awaiting liver transplantation. It is expected to help reduce mortality and alleviate complications associated with liver cirrhosis.